药品名称 | DIFLUCAN IN DEXTROSE 5% IN PLASTIC CONTAINER | 申请号 | 019950 | 产品号 | 003 | 活性成分 | FLUCONAZOLE | 市场状态 | 处方药 | 剂型或给药途径 | INJECTABLE;INJECTION | 规格 | 200MG/100ML (2MG/ML) | 治疗等效代码 | AP | 参比药物 | 是 | 批准日期 | 1992/09/29 | 申请机构 | PFIZER INC
| 化学类型 | New dosage form | 审评分类 | |
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与本品相关的专利信息(来自橙皮书Orange Book) | 专利号 | 专利过期日 | 是否化合物专利 | 是否产品专利 | 专利用途代码 | 专利下载 | 无 | 历史专利信息 | 无 |
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与本品相关的市场独占权保护信息 | 独占权代码 | 失效日期 | 无 | 历史市场独占权保护信息 | 无 |
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与药品注册相关的信息 | 申请号 | 修订号 | 审批结论 | 公开文档类型 | 文档创建时间 | 获取文档 | 019950 | 062 | AP | Label | 2014/03/25 | 下载 | 019950 | 062 | AP | Letter | 2014/03/25 | 下载 | 019950 | 061 | AP | Label | 2013/09/17 | 下载 | 019950 | 061 | AP | Letter | 2013/09/17 | 下载 | 019950 | 059 | AP | Letter | 2011/11/21 | 下载 | 019950 | 059 | AP | Label | 2011/11/21 | 下载 | 019950 | 057 | AP | Letter | 2011/04/29 | 下载 | 019950 | 057 | AP | Label | 2011/04/29 | 下载 | 019950 | 056 | AP | Label | 2011/06/06 | 下载 | 019950 | 056 | AP | Letter | 2011/06/08 | 下载 | 019950 | 053 | AP | Letter | 2010/08/10 | 下载 | 019950 | 053 | AP | Label | 2010/08/10 | 下载 | 019950 | 043 | AP | Letter | 2008/04/04 | 下载 | 019950 | 043 | AP | Label | 2008/04/16 | 下载 | 019950 | 039 | AP | Letter | 2004/03/28 | 下载 | 019950 | 039 | AP | Label | 2004/04/05 | 下载 | 019950 | 037 | AP | Letter | 2004/10/08 | 下载 | 019950 | 037 | AP | Label | 2004/10/08 | 下载 | 019950 | 033 | AP | Letter | 2004/10/08 | 下载 | 019950 | 033 | AP | Label | 2004/10/08 | 下载 | 019950 | 031 | AP | Label | 2004/10/08 | 下载 | 019950 | 031 | AP | Letter | 2004/10/08 | 下载 |
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药品注册审批历史信息 | 申请号 | 修订号 | 审批结论 | 审批日期 | 审批内容 | 019950 | 065 | AP | 2015/06/01 | Manufacturing Change or Addition | 019950 | 063 | AP | 2014/07/28 | Manufacturing Change or Addition | 019950 | 062 | AP | 2014/03/24 | Labeling Revision | 019950 | 061 | AP | 2013/09/13 | Labeling Revision | 019950 | 059 | AP | 2011/11/16 | Labeling Revision | 019950 | 057 | AP | 2011/04/26 | Labeling Revision | 019950 | 056 | AP | 2011/06/06 | Labeling Revision | 019950 | 053 | AP | 2010/08/05 | Labeling Revision | 019950 | 043 | AP | 2008/03/31 | Labeling Revision | 019950 | 039 | AP | 2004/03/24 | Labeling Revision | 019950 | 037 | AP | 2004/10/07 | Labeling Revision | 019950 | 034 | AP | 2002/08/07 | Labeling Revision | 019950 | 033 | AP | 2004/10/07 | Labeling Revision | 019950 | 032 | AP | 2001/03/05 | Control Supplement | 019950 | 031 | AP | 2004/10/07 | Labeling Revision | 019950 | 030 | AP | 1999/09/29 | Manufacturing Change or Addition | 019950 | 029 | AP | 1999/09/29 | Manufacturing Change or Addition | 019950 | 028 | AP | 1999/02/22 | Labeling Revision | 019950 | 027 | AP | 1998/02/13 | Manufacturing Change or Addition | 019950 | 026 | AP | 1997/08/05 | Labeling Revision | 019950 | 025 | AP | 1997/02/19 | Labeling Revision | 019950 | 024 | AP | 1996/08/06 | Labeling Revision | 019950 | 022 | AP | 1996/07/23 | Labeling Revision | 019950 | 021 | AP | 1995/12/22 | Control Supplement | 019950 | 020 | AP | 1995/03/20 | Control Supplement | 019950 | 019 | AP | 1995/03/09 | Control Supplement | 019950 | 018 | AP | 1994/06/30 | Labeling Revision | 019950 | 017 | AP | 1994/08/22 | Control Supplement | 019950 | 016 | AP | 1994/11/23 | Patient Population Altered | 019950 | 012 | AP | 1994/07/08 | Package Change | 019950 | 011 | AP | 1993/06/22 | Manufacturing Change or Addition | 019950 | 010 | AP | 1993/10/13 | Labeling Revision | 019950 | 009 | AP | 1993/02/10 | Control Supplement | 019950 | 008 | AP | 1993/06/14 | Control Supplement | 019950 | 007 | AP | 1993/10/13 | Labeling Revision | 019950 | 004 | AP | 1993/12/30 | New or Modified Indication | 019950 | 003 | AP | 1993/10/13 | Labeling Revision | 019950 | 002 | AP | 1992/09/29 | Control Supplement | 019950 | 000 | AP | 1990/01/29 | Approval |
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